OWNERSHIP INTERESTS AND ELECTRONIC HEALTH RECORDS: A CRITICAL TOOL
FOR GOVERNANCE
J ESSICA PATTON
1
OWNERSHIP INTERESTS AND ELECTRONIC HEALTH RECORDS: A CRITICAL TOOL
FOR GOVERNANCE
TABLE OF CONTENTS
SCIENCE AND LAW: THE UNDERLYING PHILOSOPHIES .................................................... 5
CHALLENGES IN E-HEALTH ................................................................................................ 8
THE CANADIAN POSITION ON INTELLECTUAL PROPERTY IN EHRSS ......................... 11
COPYRIGHT LAWS ............................................................................................................ 15
OWNERSHIP, ASSIGNMENTS , AND LICENCES ............................................................... 17
MEDICAL RECORD ........................................................................................................ 18
DATABASES ................................................................................................................... 21
ED IAMOND .................................................................................................................... 23
A CLINICIANS PERSPECTIVE ON DATABASES .............................................................. 25
AN INTERNATIONAL P ERSPECTIVE ON DATABASES: ................................................... 27
CONCLUSION ..................................................................................................................... 30
The adoption of electronic databases to manage health information is happening across
the globe. The current leaders in the development and implementation of electronic health
2
records are Canada, the United Kingdom (U.K.), and Australia.1 However all of these projects
appear to be side-stepping questions of ownership interests and governance. Intellectual
property (IP) is a critical tool for the governance of electronic health (e-health) information
contained in these databases.
Current laws are ambiguous with respect to Electronic Health Records (EHRs).
Electronic Health Record Systems (EHRSs) are essentially databases composed of EHRs.
Canada has a vision to create a national EHR database. Achieving this goal will require the
collaboration of federal and provincial governments, health care providers, legal professionals,
and private institutions from a number of industries including computer software and research
firms. Each of these collaborators as well as individual patients will have an interest in either the
information stored in the databases or components of the database itself. While the development
of EHRSs appears well underway, there is very little discussion with respect to how these
interests will be assigned and managed.
Medical databases have the potential to revolutionize public health research and
epidemiological studies. These secondary uses of the data increase its commercial value and the
necessity for effective governance to protect privacy rights. EHRSs raise a multitude of
questions such as concerns for privacy, security, access, and consent. Many of the answers will
hinge on questions of ownership and governance. There is a growing body of literature on
EHRS challenges, but the intellectual property laws that will govern EHRSs have been virtually
ignored.
1
Walter W Wieners, et al., “The Global Perspective” in Lehmann, Harold P. et al.,eds., Aspects of
Electronic Health Record Systems (New York: Springer, 2006) 176 [The Global Perspective]
3
The common law provides that medical records are the property of the physician, but
patients are entitled to a right of access.2 However EHRs, blur the traditional view of physicians
owning their paper files and records. Moreover, the Canadian threshold of originality to trigger
copyright protection of databases is high and unresponsive to health information and by
extension, EHRSs.
This paper criticizes the leaders of this national project for their oversight with respect to
copyright and ownership interests and seeks to promote these issues to policymakers, health care
providers, legal practitioners and the public at large.
The analysis of copyright in medical databases is conducted using a variety of methods.
In order to provide a perspective on the issues, the underlying philosophies of science and
intellectual property law are briefly discussed so as to highlight their differences. A more
detailed description of medico-legal issues emerging as a result of EHRSs in other jurisdictions
in then considered, followed by a review of Canadian federal policies on intellectual property in
EHRS development.
The body of this paper reviews relevant provisions of the Copyright Act, the common law
principle of medical record ownership, and the copyright protection of databases. The
interaction of these legal principles will significantly impact the governance and ownership
interests in EHRs. The discussion is brought to a more practical level by reviewing a U.K. case
study as well as the documented findings of an interview with a prominent Canadian clinical
researcher and practicing physician. In closing, the current directions of database laws are
reviewed prior to consideration of three possible models for IP ownership in e-health.
2
McInerney v. MacDonald, [1992] 2 S.C.R. 138 [McInerney]
4
SCIENCE AND LAW: THE UNDERLYING PHILOSOPHIES
The scientific research community functions on principles of open access and community
collaboration. The classic principle of open science was best articulated by Robert Merton in the
late twentieth century.3 The Mertonian norms of science consist of five principles or
expectations; universalism, disinterestedness, communality, organized skepticism, and
originality.
Universalism is the expectation that scientists will judge empirical claims according to
impersonal criteria, without regard to the identity of the author. Disinterestedness is the
expectation that scientists will subordinate their own biases and interests to the advancement of
knowledge. Communality is the expectation that discoveries will be freely shared and
disseminated to the community of scientists. Organized skepticism is the expectation that
scientists will subject empirical claims to systematic scrutiny and validation. Originality is the
expectation that contributions to the fund of scientific knowledge will be valued for their
novelty. Collectively these principles result in a norm to produce the reputational rewards for
open science4.
These principles are rather theoretical and impractical due to financial pressures since
academic research is typically funded by private institutions, detracting from their
independence.5 However, Dan Burk, a specialist on on the intellectual property implications of
global computer networks, observes that the Mertonian framework nonetheless continues to
Dan L. Burk, “Intellectual Property Issues in Electronic Collaboration,” in Koslow S. and Huerta
M. eds., Electronic Collaboration in Science: Progress in Neuroinformatics, Volume 2 (Mahwah, N.J.: Lawrence
Erlbaum Associates, 2000) 15 at 11[Burk E-Collaborations] and Burk, Dan L. “Intellectual Property in the context
of e-Science” (2006) 12:2 Journal of ComputerMediated Communication [Burk IP in e-Science] at 6.
4
Burk IP in e-Science Ibid at7
5
Ibid at 7
3
5
resonate with the scientific community and has provided a useful lens through which to view the
collision of open science and proprietary intellectual property.6
Intellectual property law, by its very nature restricts access to information. Broadly
speaking, the term intellectual property refers to three discrete areas of law; copyright, patents,
and trade secrets. Intellectual property provides the legal basis to exclude, mimicking the
physical phenomenon that arises naturally with tangible objects or real property. Tangible
property and intellectual property however are distinct interests in any piece of property. For
example, can physically own a book upon its purchase but the purchase of the book grants no
rights to the intellectual property it contains.
The two most common justifications for the legal protections of intellectual property, and
more specifically copyright protection, are utilitarian and natural rights.7 The utilitarian
approach views intangible property rights as an economic incentive for more creation which is
useful to society; whereas the natural rights approach is much like the labor theory seeking to
reward creators for their work. The justification for intellectual property rights run afoul to the
community shared behavior that thrives in scientific research. Scientists are expected to freely
share and contribute their discoveries with the community; such contributed knowledge is vetted
through criticism and peer review of published papers or reports.8 The motives to achieve the
collaborative goals in science are not traditionally fuelled by monetary incentives. The
proprietary interests of intellectual property are viewed by some scientists as at best, unnecessary
and at worst, counterproductive.9
6
Ibid at 7
Teresa Scassa, “Interests in the Balance” in Michael Geist, ed., In the Public Interest: The Future of Canadian
Copyright Law (Toronto: Irwin Law, 2005) 41 at 42 [Scassa].
8
Burk IP in e-Science supra note 3 at 6
9
Burk E-Collaborations supra note 3 at12
7
6
An excellent illustration of this disconnect arose with the Genome Mapping Project.
During the sequencing of the genome, controversy arose with respect to who would own the
patent. Sequencing was time consuming and undertaken by a combination of public and private
institutions. The U.S. government originally sought to patent the sequence to block private
patenting attempts. The initiative was abandoned due to opposition by the scientific community
because it violated the Mertonian norms of communality.10 Subsequent efforts to patent the
sequences by private industry were met with hostility. Publicly funded sequencing laboratories
agreed on a collective patent-defeating strategy which required academic researchers to deposit
their sequence data in publicly available repositories on the Internet within hours of the data
generation.11 This rendered any attempt to patent the sequence invalid because it vitiated the
novelty requirement of patent law. The scientific community was successful in their strategy
and in reinforcing the commitment to open science.
The differences in the underlying philosophies in intellectual property and open science
reflect the inherent difference in use and practice. While both philosophies are arguably dated
and open to review, they are nevertheless relevant to e-health issues because the differences will
to a considerable extent, serve as a partial explanation about the lack of unity between public and
private research interests.
Clinicians and health care institutions have traditionally given little regard to the
formalities of intellectual property and ownership rights.
This issue will be explored in more
detail in the latter half of this paper through the U.K. project, IMaGE.
10
11
Burk IP in e-Science supra note 3 at 7
Ibid at 7
7
It was reported in the IMaGE project, that current practices of medical data sharing
occurs on a level of trust, often based on long-term research relationships.12 These relationships
involve data-sharing and are beginning to increasingly involve private industry for funding.
However the ways in which these arrangements are orchestrated are often ad hoc and made on a
local basis.13 Ultimately, a lack of clarity on these issues will either lead to a complete
unwillingness to share data or costly litigation upon conflicting claims.14
CHALLENGES IN E-HEALTH
The concept of e-Health is continually adapting to changes in the health care system.
Broadly speaking e-Health encompasses any area of health care that is shifting from a paper
based format to an electronic format. More formally, it is the delivery of both health care
services and health care information by electronic medium through the use of information
technologies.15 An understanding of e-health therefore encompasses a broad spectrum of
activities, yet observers do not consider e-health as encompassing health service delivery that is
completely or even primarily on the Internet.16 For the purposes of this paper, the sector of ehealth in focus is that relating to patient medical information obtained by clinicians and stored in
an electronic database, often referred to as the electronic health record (EHR) or a part thereof.
By definition, databases are a compilation of information arranged in a systematic way
and offering a means of finding specific elements it contains, often today by electronic means.17
EHR is an expansive term referring to an interoperable electronic patient record that collects
information from numerous systems, including computer-based patient records (CPRs),
Giuseppina D’Agostino. et al., “On the Importance of Intellectual Property Rights for e-Science and the
Integrated Health Record” Health Informatics Journal [forthcoming in 2007] at 3 [IP and the Integrated Health
Record]
13
Ibid at 4
14
Ibid at 4
15
Callens, Stefaan. E-Health & the Law (Kluwer Law International 2003) at 4 [E-Health & the Law]
16
Ibid at 5
17
Black’s Law Dictionnary, 8th ed., s.v. “database”
12
8
electronic medical records (EMRs) and electronic patient records (EPRS) that reside in various
provider settings.18 The broadest term is electronic health record systems (EHRSs) which refers
to a collection of EHRs .19
EHRSs have been the subject of increasing attention of the last decade in both the
medical and business worlds. The number of mentions of EHRSs in PubMed has increased by
about 3000 annually, totalling over 36, 000 mentions in the last ten years.
However, the
proportion of EHRS references representing scientific research is lower, indicating that the focus
has been largely on implementation and practice.20 In business literature, there was only a total
of 950 mentions in the last 10 years. However the number of mentions doubled from 100 to over
200 in 2003. 21
The world of research, particularly biomedical research, has undergone significant
changes in the face of new technology and data sharing. Collaborations in research have the
potential for substantial benefits but also present numerous legal issues. Undefined ownership
issues will curtail the utility of medical databases and collaborative projects if left unaddressed
until a dispute erupts. Dan Burke states:
Crucial aspects of these determinants are centered upon ownership and control
of the information and tools associated with e-science. And, while it is by no
means the only legal regime that will affect these aspects of e-science,
intellectual property law is expected to play a major role in determining such
ownership and control.22
Two recent examples can be used to demonstrate how undefined collaboration can halt
progress in EHRS development. In December of 1998 the parliament of Iceland passed a Bill
that allowed for the creation of a centralized database of all the Icelandic peoples' genealogical,
Harold P Lehmann,. “Aspects of Electronic Health Record Systems” (New York: Springer, 2006) at 2.
Ibid at 2
20
Ibid at 2
21
Ibid at 2
22
Burk IP in e-Science supra note 3 at 2
18
19
9
genetic, and personal medical information. In 2000 Iceland’s Ministry of Health granted an
exclusive license to DeCode, a genetic biotechnology company, to access the national health
records and create the Icelandic Health Sector Database. The rights granted included not only
the right to analyze the data but also the rights to commercializing and market the personal
medical records. Prior to the passage of the Bill, deCode had signed an agreement with
Hoffman-LaRoche, a Swiss pharmaceutical giant, in anticipation of the contract.23 The
commercial value of this genetic data arises as a result on the unique gene pool of Icelanders.
Icelanders' genes remain largely unchanged from Viking days, and modern DNA techniques
provide science a golden chance to unravel the roots of major ailments by charting the progress
of a cancer or heart disease through a family and isolating DNA markers from relatives.24
The contract with DeCode was opposed by on two fronts. First, the medical community
and citizens had serious concerns ethics, privacy, and security. Second, the scientific research
community was also opposed to a legalized monopoly of genetic research on the basis that it
would threaten academic freedom in Iceland.25 The health database currently appears to remain
empty.26 The debacle illustrates that medical data may has different importance and value to
each of its potential users.27 Further, the Iceland experience raised important questions as to how
Oksana Hlodan. “For Sale: Iceland's Genetic History” American Institute of Biological Sciences (June 2000),
online: ActionBioscience.org: http://www.actionbioscience.org/genomic/hlodan.html
24
Robin McKie. “Icelandic DNA project hit by privacy storm” The Observer (16 May 2004) online:
http://observer.guardian.co.uk/international/story/0,6903,1217842,00.html
25
Bogi Andersen. “Icelandic Health Records” (1998) 282:5396 Science 1991, online:
http://www.sciencemag.org/cgi/content/full/282/5396/1991e
26
Pat McCaffrey. “Iceland's DeCode Genetics Struggles Toward Goal of A Nationwide Medical Records Database”
(1 April 2003) online: CIO.com
http://www.cio.com/article/31817/Iceland_s_DeCode_Genetics_Struggles_Toward_Goal_of_A_Nationwide_Medic
al_Records_Database
27
IP and the Integrated Health Record supra note 12 at 6
23
10
the secondary use and access to databases by third party organizations and bodies will be will be
governed.28
The second example recently occurred in the Australian EHRS initiative. In an attempt
to establish data standards for communication between pharmacies, consumers and government
agencies, the Australian Department of Health funded a project to be carried out by the pharmacy
guild and a private consulting firm.
The project, known as “Better e-Dispensing” and “e-
Claiming”, exceeded the government budget of $3 million by $1.5 million. However, in 2002
the guild and the consulting firm jointly applied for worldwide patents for a “method and system
for sharing personal health data.”29 Australia IT reported that the bid sparked outrage from
doctors, consumers, and industry groups also collaborating on local e-health initiatives. In July
of 2007, the guild assigned its interest to the Commonwealth and in August of 2007 the
government withdrew the application prior to formal determination by the IP regulatory body. 30
If it has been successful, the patent would have had numerous impacts on the
development of EHRSs. The guild could have charged royalties on government IT systems such
as the HealthConnect, the national EHRS initiative, as well as charging licensing fees to software
developers for using medication management features.
THE CANADIAN POSITION ON INTELLECTUAL PROPERTY IN EHRSS
The Canadian initiative to modernize health care began in the early 1990’s upon
recommendation of the Information Highway Advisory Council (“IHAC”). In 1999 the IHAC
released their final report, ‘Canada Health Infoway: Paths to Better Health’, which recommended
the establishment of a nationwide health infoway, to improve the quality, accessibility and
28
Ibid at 7
Dearne, Karen. “ Patents bid quietly laid to rest” Australian IT (23 October 2007), online:
http://www.australianit.news.com.au/story/0,24897,22630718-15319,00.html
30
Ibid
29
11
efficiency of health services across the entire spectrum of care in Canada.31 In the 105 page
document, the single reference to intellectual property issues reads as follows.
The Council believes that government has the responsibility to define clearly its
approach to public-private collaboration and transparently examine its implications
in light of the following principles. [. . .] As part of the normal contracting process
where intellectual property with a potential for commercialization is likely to be
developed, the return to the parties should be in line with the contributions made
and the risks assumed by the parties. To the extent possible, commercialization of
intellectual property should occur in Canada.32
In 2000 following the release of this report, the federal government established Canada
Health Infoway Inc (Infoway) as an independent, not-for-profit corporation with the national
mandate to accelerate the implementation of EHRs. The initial investment of $500 million was
continually increased and by 2004 Infoway’s total capitalization was $1.2 billion. Following
their mandate, in January 2001, Infoway released their report “Toward Electronic Health
Records.”33 This 53 page report does not refer to intellectual property once. However, the
following statement is made regarding the ownership of EHRs:
Related to the previous issue is the question of ownership or stewardship of the
EHR. It may be assumed that provincial/territorial governments or regional
boards will administer the EHR, but if current health care trends continue, this
assumption may be challenged.34
And finally in April 2006 Infoway released its report ‘EHRS Blueprint: An interoperable
EHR Framework’.35 This report made no reference to ownership of intellectual property.
However, a thorough search of their website revealed that in 2001 the Board of Directors
31
Federal Advisory Council on Health Infostructure, Canada Health Infoway: Paths to Better Health Final Report
(1999) ,online: Health Canada < http://www.hc-sc.gc.ca/hcs-sss/pubs/ehealth-esante/1999-paths-voiesfin/index_e.html >
32
Ibid at 21
33
Office of the Health and the Information Highway Health Canada, Towards Electronic Health Records (Ottawa
Canada, January 2001), online: Health Canada < http://www.hc-sc.gc.ca/hcs-sss/alt_formats/iacbdgiac/pdf/pubs/2001-towards-vers-ehr-dse/2001-towards-vers-ehr-dse_e.pdf>
34
Ibid at 24
35
Canada Health Infoway Inc. EHRS Blueprint: An interoperable EHR Framework (April 2006) online:
http://knowledge.infoway-inforoute.ca/EHRSRA/doc/EHRS-Blueprint-v2-Exec-Overview.pdf
12
released the “Intellectual Property Policy of Canada Health Infoway Inc.”36 In effect this policy
states that Infoway has total control of any IP used or generated in the course of the EHRSs. In
summary the Infoway policy requires Infoway’s (“the Corporation”) approval prior to the
transfer of any rights to a third party via license, assignment or otherwise, before granting or
agreeing to grant to any third party any exclusive license or other interest in and to any
Investment Derived IP. The Corporation may require Participants to grant one or more licenses
to the Corporation in respect of any Investment Derived IP on a royalty-free basis for academic
or non-commercial purposes, and to be considered on a case-by-case basis. In addition, the
Corporation may, in certain circumstances, consider it appropriate to retain or acquire a royalty,
participation, ownership and/or other interest in and to Investment Derived IP to be assessed on a
case-by-case basis. And finally, the Corporation shall seek to ensure that any publication or
presentation in respect of the Investment Derived IP should contain an appropriate
acknowledgement of the Corporation’s role in the Investment.37
This “policy” only renders the situation more opaque and may serve to partially explain
why sustaining private funding investments continues to be a challenge for Infoway.38
It seems unlikely that this corporation dedicated exclusively to the development of
EHRs, did not identify intellectual property as a governance tool for information management.
In an interview conducted by David Wattling, Managing Partner with Courtyard Group and
Founding Chair of CHITTA - Canada's Healthcare Information Technology Trade Association
with Myrna Francis, Senior Vice-President of Strategic Alliances, Canada Health Infoway, , the
following exchange took place:
“Intellectual Property Policy Of Canada Health Infoway Inc./ Inforoute Santé Du Canada Inc.” (Adopted by the
Board of Directors, December 10, 2001) online:
<http://www.infowayinforoute.ca/Admin/Upload/Dev/Document/IntellectualPropertyPolicy.pdf>
37
Ibid
38
The Global Perspective supra note 1 at 188-9
36
13
DW: With a pan-Canadian mandate and a bias towards solutions that have
national applicability, how will Infoway handle issues of proprietary intellectual
property, notably among the private sector partners?
MF: That depends on the starting point. If the project creates [sic] net new [sic]
IP then the public sector sponsor would own the IP. If the vendors come in with
IP that is commercial, then it is theirs [sic] and the opportunity presents for a
discussion of national licenses. The intent is to ensure that the IP is dealt with in
a way that enables us to move across the country and not be doing one-offs in
every jurisdiction or organization.39
At best, this response seems incomplete. With the cost of health care continually rising,
currently sitting at almost 10% the GDP in Canada40 government funding for the health care
system is already over stretched leaving no resources for licensing and royalty fees in the system.
Some advocates of EHRSs argue that Canada is falling behind on both implementing and
investing in our national EHRS.41
After reviewing the intellectual property policies, or perhaps lack thereof, outlined by the
government for the development of EHRSs, a review of the legislative framework may provide
further clarity. Intellectual property laws like many areas of law, provide the default rules for
private parties in the absence of agreement stating otherwise. After examining the default rules
of the current laws, contracts assigning intellectual property rights will be explored below.
As discussed earlier, ownership of EHRs falls into to two broad categories governed by
two distinct bodies of law and jurisprudence; the database holding the information and the
information itself. The Copyright Act protects both databases as compilations and the medical
record as a ‘scientific work.’ The ownership of medical records is also governed by the common
law and the Public Hospital Act42. Both of which are discussed below.
“Infoway talks about alliances, partnerships and collaborations” (Canada Health Infoway) online:
http://www.infoway-inforoute.ca/en/News-Events/MediaCoverage_long.aspx?uid=17
40
Organisation for Economic Co-operation and Development. OECD health data 2006: statistics and indicators for
30 countries ( Paris: OECD Publishing 2006)
41
“Power failure for e-health” The Toronto Star (29 April 2007) A14
42
R.S.O. 1990, c. P.40
39
14
COPYRIGHT LAWS
Copyright falls under federal jurisdiction by virtue of the Constitution Act.43 The
Copyright Act44 (the Act) was enacted in 1921, came into force in 1924, and was based largely
on the 1911 UK copyright law.
Copyright protection was originally a “professional right”, that is a right used by
professionals against other professionals, a privilege granted to authors and publishers to prevent
reuse by other publishers.45 However the scope of copyright protection evolves with technology
and the information age has significantly broadened the scope of protected works. The scope of
protection generally grows by analogy46 so that an electronic multimedia work or database
should also be as fully protected as the traditional encyclopedia or card-index.47
Copyright protection prohibits copying the expression of the original work. Simply put,
copyright deters copying of the particular expression, but allows ideas to be freely re-used.48
Copyright does not protect facts, processes, machine, functional or utilitarian items. Nor does it
protect industrial designs for mass-produced items like automobiles or dishwashers. These
items are dealt with under the Industrial Design Act. However, copyright does cover more
traditional texts, such as scientific reports and journals and has become increasingly important to
technological innovation.49
The purpose of the Act is not expressly outlined in the statute. However the underlying
philosophies discussed earlier, the natural and utilitarian approaches, are often stated as the
43
Constitution Act, 1867
R.S.C. 1985, c. C-42
45
Daniel Gervais. “The Purpose of Copyright Law in Canada” (2005) 2:2 UOLTJ 315 at para 27[Purpose of
Copyright]
46
Ibid at para 29
47
David Vaver. Intellectual Property Law: copyright, patents, trademarks (Concord:Irwin Law, 1997) at 21[Vaver
IP]
48
Burk IP in e-Science supra note 3 at 3
49
Ibid at 3
44
15
purpose for the Copyright Act.
The latter approach argues that “the economic purpose of
copyright law is instrumentalist in nature, namely, to ensure the orderly production and
distribution of, and access to, works of art and intellect.”50 While the courts have been reluctant
articulate the purpose, recent judicial interpretation appears to support the economic incentive
approach, which is now referred to as the balanced approach. In Theberge v. Galerie d'Art du
Petit Champlain Inc. et al51, the Supreme Court of Canada adopted a utilitarian approach,
seeking "a balance between promoting the public interest in the encouragement and
dissemination of works of the arts and intellect and obtaining a just reward for the creator."52
This approach was later used by the Supreme Court in CCH Canadian Ltd v. Law Society of
Upper Canada.53
Copyright protection is automatic upon fixation and the term of protection is fifty years
after the authors’ death54. Upon expiration works enter the public domain, the body of
information for which there is no proprietary right within a particular jurisdiction.
The concept of originality sets the boundaries of copyright law but the term “original” is
not defined in the Act. Section 5 of the Act states that, in Canada, copyright shall subsist "in
every original literary, dramatic, musical and artistic work." Initially, the court set a low
threshold for originality requiring on that the work was not copied and there was minimal
intellectual effort. “The Act does not require that the expression must be in an original or novel
form, but that the work must not be copied from another work [. . .] There remains the rough
practical test that what is worth copying is prima facie worth protecting.”55 The U.S. courts have
50
Purpose of Copyright supra note 45 at para 2.
[2002] 2 S.C.R. 336, 285 N.R. 267 [Theberge]
52
Ibid at para 30
53
[2004] 1 S.C.R. 339, 236 D.L.R. (4th) 395 [CCH]
54
It is noteworthy that both the U.S. and the U.K. have 70 year terms of protection after that authors death.
55
University of London Press Ltd. v. University Tutorial Press Ltd., [1916] 2 Ch. 601 at page 6 and 7
51
16
used a much higher standard for originality, requiring that for a work to be original it must be
creative56. The Supreme Court of Canada recently adopted the middle ground between the two
standards of originality. In CCH Canadian Limited v. The Law Society of Upper Canada, Justice
McLachlin, for a unanimous court states that:
“For a work to be "original" within the meaning of the Copyright Act, it must be
more than a mere copy of another work. At the same time, it need not be
creative, in the sense of being novel or unique. What is required to attract
copyright protection in the expression of an idea is an exercise of skill and
judgment. [. . .] This exercise of skill and judgment will necessarily involve
intellectual effort. The exercise of skill and judgment required to produce the
work must not be so trivial that it could be characterized as a purely mechanical
exercise.”57
Therefore creative works are by definition “original” but creativity is not necessary to make a
work “original”. This standard will be returned to later with respect to data compilations.
OWNERSHIP, ASSIGNMENTS , AND LICENCES
The Act states that the author, the creator, of the work shall automatically be the first
owner of the copyright,58 with two exceptions. In the context of employment where “the work
was made in the course of his employment by that person, the person by whom the author was
employed shall, in the absence of any agreement to the contrary, be the first owner of the
copyright”59, save where the work is an article or other contribution to a newspaper, magazine or
similar periodical.60 The second exception applies to engravings, photographs or portraits, the
plate or other original. The person by whom the plate or other original was ordered, where
consideration was paid, shall be the first owner of the copyright61.
56
Feist Publications Inc. v. Rural Telephone Service Co., 499 U.S. 340 (1991) [Feist Publications]
CCH supra note 53 at para 16
58
s. 13(1)
59
s. 13(3)
60
This is exception does not exist in Europe.
61
s. 13(2)
57
17
In the absence of a contractual agreement, the aforementioned rules determine the owner
of the copyright. Where parties seek to assign ownership along other terms, the contracts are
usually in the form of licences and assignments. These contracts, properly drafted and on
reasonable terms clear to both parties, trump the default governance of copyright as prescribed
by the Act.
An assignment is the outright transfer of rights or property. It effectively changes
ownership from assignor to assignee.62 By contrast, a licence is an agreement or permission to
commit some act that would otherwise be unlawful. Licences may be exclusive, sole or nonexclusive. An exclusive licence, most resembles an assignment, it grants the licensee the power
to exercise the right to exclude all others including the licensor. A sole licence authorizes
slightly less control in that it grants the licensee exclusive rights to the licence but does authorize
the right to exclude the licensor. Lastly a non-exclusive licence implies that other licensees may
also be appointed to compete with one another and the licensor.
Assignments are more formal in nature, and to be given full legal force, the agreement
must generally be in writing and signed. Licence agreements are generally less formal, they can
be expressly be defined by contract but may also be implied.
These contractual provisions, like all contracts, are subject to judicial interpretation and
construction. Unfortunately, these terms are often used interchangeably and create hybrid
relationships leaving the decision largely to the discretion of the courts.
MEDICAL RECORD
The law must protect both the privacy rights of patients and the legitimate interests of
physicians by clearly defining the identity and extent of ownership and rights of access to
62
Vaver IP supra note 47 at para 241
18
electronically-stored patients’ medical data. The Ontario Public Hospitals Act63 mandates that
the record of personal health information compiled in a hospital for a patient is the property of
the hospital and shall be kept in the custody of the administrator.
In McInerney v MacDonald the Supreme Court of Canada stated that a physician owns
the medical record of their patients but patients are entitled to a right of access64. The right of
access is based not on proprietary rights of ownership, but on the fiduciary duty of the health
care provider. The distinction between a proprietary right of ownership and right of access is
subtle but important. The right of access is a qualified right of individuals to inspect and copy
their own health information.65
This principle of individual access has also been echoed by the CMA’s Health
Information Privacy Code, which states that patients have the right of access to their health
information but in rare and limited circumstances health information may be withheld from a
patient if there is a significant likelihood of a substantial adverse effect on the physical, mental or
emotional health of the patient or substantial harm to a third party. The onus lies on the provider
to justify a denial of access.66
The right of access stems from privacy rights. Privacy and intellectual property are
inherently intertwined. Enhancing ownership rights of authors detracts from privacy rights users,
and in the case of medical records, from the privacy of patients.
The privacy implications of
EHRSs are under scrutiny and have been explored in some detail.67 Where privacy rights end,
63
R.S.O. 1990, c. P.40
McInerney supra note 2
65
Lorne Elkin Rozovsky & Noela J. Inions, Canadian Health Information : A Practical Legal and Risk
Management Guide (Markham: Butterworths, 2002) at 72.
66
Canadian Medical Association Health Information Privacy Code, online: Policy/Advocacy,
http://www.cma.ca/index.cfm/ci_id/3216/la_id/1.htm#prin6
67
see for example: Ries, Nola M. “Special Issue: Privacy Law; Patient Privacy in a Wired (and Wireless) World:
Approaches to Consent in the Context of Electronic Health Records (2006) 43 Alta. L. Rev. 681.
64
19
ownership rights begin. To delineate or separate these two rights is crucial for the effective
governance of EHRSs and health information generally.
Medical records are protected under the act as an original scientific work.68 The
employee exception would not apply to the physician because in Canada, physicians are not
employees of hospitals69. For copyright purposes it is unclear whether physicians could be
classified as independent contractors or employees of the government and therefore vest
copyrights ownership in the government in the absence of a contract agreement. It should be
noted that McInerney arose in New Brunswick where there is no legislation on this issue. The
court said that in the absence of legislation, a patient is entitled to examine and copy all
information in the medical record. However, the issue at hand is how will e-health and EHRs
change the right of access and the ownership of the physician? Will a medical record still be
considered an original scientific work in a standardized EHRS? Other issues such as whether or
a not a patient will be able to access medical records online and how a patient will be able to
interpret and challenge any information are also important issues, but they are beyond the scope
of this paper.
In a White paper released earlier this year, Infoway noted the initiative of the Canadian
Medical Association (CMA) to ensure physicians remain the custodians of physician-generated
health information in the primary care or non-institutional setting. The CMA has also made
recent initiatives to raise awareness about data stewardship in the face of concerns about the
development of large data repositories.
The White paper notes that even though custodians and their obligations are often defined
in statutes, data custodianship or trusteeship is still a controversial issue in electronic health
68
69
Copyright Act s.2
Public Hospitals Act, R.S.O. 1990, c. P.40
20
record environments. Further, although it may be discerned from the statutes as to who the
custodian is in a single organization or for a single domain repository, the custodianship of the
shared health record remains unclear.70
The obligations and duties of custodians as information passes from jurisdiction to
jurisdiction are very unclear. In fact, the vision of a pan-Canadian health network runs
contradictory to the provincial governance of health care. This is further complicated by the fact
that copyright laws are federal while privacy legislation governing health information is
provincial.
DATABASES
Databases are protected in the Copyright Act71 under “compilations”, defined as a work
resulting from the selection or arrangement of literary, dramatic, musical or artistic works or of
parts thereof, or a work resulting from the selection or arrangement of data.72
To warrant protection the collections of data must be arranged in an original manner, not
incidental to the collection of the data. Simply gathering and sorting the data in an obvious way
does not imply the “selection or arrangement” as prescribed by the Act. Generally speaking
where the arrangement is alphabetical, or too commonplace and mechanical to be original, it may
not warrant protection.73
70
Canada Health Infoway Inc. White Paper on Information Governance of the Interoperable
Electronic Health Record (EHR) (March 2007) online: http://www.infowayinforoute.ca/Admin/Upload/Dev/Document/Information%20Governance%20Paper%20Final_20070328_EN.pdf
see also “Canadian Medical Association,“Information Technology was a Top-of-Mind Issue for Delegates Attending
the CMA Annual Meeting in Edmonton Last Week” online: at
http://www.cma.ca/index.cfm/ci_id/45344/la_id/1.htm
71
R.S.C. 1985, c. C-42
72
Copyright Act s.2
73
Feist Publications supra note 56
21
The World Intellectual Property Organization (WIPO) Copyright Treaty raises another
important issue with respect to databases. Article 5 states that compilations of data or other
material, in any form, which by reason of the selection or arrangement of their contents
constitute intellectual creations, are protected. This protection does not extend to the data or the
material itself and is without prejudice to any copyright subsisting in the data or material
contained in the compilation.
The protection of databases under copyright laws is weak but the the value of data
compilations in the coming information economy can be under-estimated. Dan Burk comments:
“The orderly selection and arrangement of data has long been central to
the practice of science, but commercial creation and exploitation of databases
not only for scientific research, but for education, finance, marketing,
entertainment and other purposes now comprises a substantial service sector.
Publishers of such databases will be seeking commercial rewards, rather than
reputational rewards, for the time and effort required to compile and arrange
such data. Even non-commercial researchers will find themselves under
increasing pressure to hold their data compilations proprietary, or risk seeing
their efforts captured and incorporated into commercial databases.”74
The Supreme Court of Canada was recently grappling with issues of electronic database
rights in the context of freelance authors and newspaper publishers in Robertson v. Thomson
Corp.75 The 5:4 decision has been criticized as effectively meaningless.76 The court found
authors own online rights and newspapers own CD-ROM rights. While carving out CD-ROM
right seem perverse in itself, freedom of contract and the unequal bargaining power of freelance
authors relative to publishers renders the decision futile. While the decision is not factually
applicable to EHRSs it serves as an opportune warning to the legislator. The information
technology revolution has brought with it many challenges that are best suited for parliament and
74
Burk E-Collaborations supra note 3 at 19
[2006] 2 S.C.R. 363
76
D'Agostino, Giuseppina “Copyright Fight Far From Over” Masthead Jan/Feb 2007, 7
75
22
its advisory committees not only to avoid the perils of isolated ad-hoc judicial decisions, but to
spare the public health system the cost of this pointless litigation.
ED IAMOND
A U.K. case study, called IMaGE (IP rights in Medical Data in a Grid
Environment), conducted a retroactive study surrounding an e-health collaboration. The eDiamond project was an initiative to support breast cancer research and screening on a national
level. The research data, digital mammographic images and patient information, was stored in a
database supported by grid technology. The collaboration was widespread at over 12 locations
and involved numerous universities, trusts (hospitals), a global computer firm, and a university
spin-out enterprise. The goal of the study was to determine the IP right in collaboration.
The laws applying to eDiamond are complex but those most applicable are the U.K.
Database Regulations77 and the EC Database Directive78 (further discussed below). eDimaond
conformed to the legal definition of a database of outlined by the U.K. Database Regulations, as
it is a collection of images that are separable from one another without affecting their value and
have been systematically or methodogically arranged to be independently accessible from a fixed
hardcopy or electronic base.79
The IMaGE study found that three types of copyright may attach to individual
mammograms (MMR); the copyright attaching to the actual image, copyright in the annotations,
and copyright in the entire record. In eDiamond, the trust retained ownership of the original and
likely the digitized images as well. In three out of four trust-university relationships this was the
77
Copyright and Rights in Databases Regulations 1997, S.I. 1997 No. 3032
Directive 96/9/EC of the European Parliament and the Council of 11 March 1996 on the legal protection of
databases
79
D’Agostino, Giuseppina. et al., “IP Rights in Medical Data in a Grid Environment (IMaGE): Challenges to
Copyright Law and Database Law” in Knowledge Rights – Legal, Societal and Related Technological Aspects
(Oesterreichische Computer Gesellschaft 2006) at 6
78
23
result of an implied license, of undefined scope, based on communication. In the absence of a
contract, the trusts were considered independent contractors and creators of the data, obtaining
ownership by default. The true creators of the data, the radiographers and technicians, fell into
the employee exception of the Copyright Act because there were no contracts in place to assign
rights otherwise.
Interestingly, an independent clinical assistant paid by the university to work at the clinic,
created ambiguity and an unintended result. Because the clinician was bound to the clinic only
by an honorary contract, the data generated would either fall under her ownership or that of the
university. The authors of the study noted that uncertainty in these rights results in an
incomplete database when carving out ownership rights.80
Moreover, there is also copyright vested in the entire database of data whether textual or
image form. Because eDiamond coordinated the scanning, sorting and overall layout of the data
in the database, they would likely meet the originality standard for an “arrangement.” However,
during this collaboration, two of the clinics involved also contributed pre-existing databases to
the eDiamond project which may also warrant separate copyright within the larger database.
The IMaGE study reported that one eDiaMoND team member remarked: ‘We initially
said to [our] lawyers, “who owns the data?”, and they never came back with an answer!’81 They
further remarked that ownership is a question of discovering and applying relevant intellectual
property laws, contracts and legislation balanced against the practical realities of who actually
possesses and controls the data (individually and as databases).
80
81
IP and the Integrated Health Record supra note 12 at 15
Ibid at 5
24
A CLINICIANS PERSPECTIVE ON DATABASES
The ambiguities of health information ownership are seen at the primary care level. To
further investigate these issues albeit on a smaller and less formal scale, an interview was
conducted with a prominent clinician, Dr Gideon Koren was interviewed at The Hospital for
Sick Children.82 Dr Koren is a researcher, practicing physician and director of a program called
Motherisk. Motherisk was established in 1985 and currently operates out of The Hospital for
Sick Children in Toronto, Ontario. The program is a resource for evidence-based information
about the safety or risk of drugs, chemicals and disease during pregnancy and lactation. The
interview was requested with the sole purpose of discussing the legal ownership of the database.
Patients join the program voluntarily to receive information and health advice. The
information obtained from patients is used to conduct observational studies on the effects or risks
of drugs, chemicals and disease during pregnancy and lactation. At present Motherisk data is
recorded manually by staff and stored in microfiche format.
Dr Koren initially expressed his belief that the data in the program was owned by the
patients or alternatively was the property of the hospital as mandated by the Hospital Act. He
suggested that the proprietary interest of the data by the clinic was more akin to governance
rather than absolute ownership. Dr Koren further expanded on this idea with the example that if
he were to change hospitals the data would not move with him. He was not aware of any
contracts between himself and the hospital assigning ownership interests with respect to his work
or the Motherisk data. He later admitted that as a “knee-jerk instinct” he would purport to own
the data but in actual fact it likely belongs to the patient.
82
Interview, Dr Gideon Koren at The Hospital for Sick Children November 21, 2007, reproduced with permission.
25
When asked how he would react to a request to use the data by another researcher
(academic or private not specified), he stated that his response would depend on the use of the
nature of the research. If the proposed study had the same or competing rationale of his
research, he might hesitate but for other purposes he would comply and promote open science.
Dr Koren did not perceive his data to have significant commercial value. He did not see
“property” in the aggregate of patient data because the data was not an “innovation”. However,
it was revealed during the interview that the Motherisk program is currently in the midst of
planning its conversion to electronic form scheduled to occur in the next few months.
The conversion is being funded by a third party, unidentified U.S. commercial
(pharmaceutical) entity that manufacturers a drug for morning sickness. The company has
requested that Motherisk collect the data in order to enable them to report to the government for
the purposes of post-market surveillance. The corporate identity has thus far invested $400 000
into the implementation of the program. He believes that the soft-ware is “off-shelf” and stated
the private entity was working in collaboration with the IT department at the hospital to ensure
security and protection of the data. He stated that the data would continue to be owned by Sick
Kids. The company requested that the Motherisk staff ask 10 pre-determined questions to
patients on behalf of the company.
He further stated the company could never block them from publishing the data or their findings
and emphasized the importance of transparency in the research process. Dr Koren further
indicated that issues of access were discussed at length with the private partner on both an
internal and external level. Internal levels of access will be arranged hierarchically and external
access seemed less clear.
26
Dr Koren expressed the opinion that collaborations with the private sector were superior
to those with the government. He explained that several years ago Health Canada proposed to
fund the electronic conversion of Motherisk but the project failed due to lack of “leadership” on
behalf of the government.
Given the information received it would appear that the staff would be the creators of the
data but subject to the employee exception, vesting ownership in the clinic or the hospital subject
to employment contracts. Many of the staff members are actually graduate students studying
under the supervision of Dr Koren. The graduate students are likely bound by a contractual
agreement with the university and subject to the terms in place their work could vest some
interests in the university.
AN INTERNATIONAL P ERSPECTIVE ON DATABASES:
To address the weak protection of databases, some nations have enacted novel forms of
database protection. The European Union, is the global leader in this trend and has implemented
a EC Database Directive83 requiring member states to enact a sui generis or novel form of
intellectual property protection, prohibiting the unauthorized extraction of information from
proprietary collections of information.84 The directive grants new proprietary rights in a broad
range of both electronic and non-electronic collections of material created through a substantial
investment of time and money. The rights include use or extraction of a substantial portion of
such collections for fifteen years; a new fifteen years begins each time the database is added to. 85
But most importantly, this directive includes a reciprocity provision meaning that this new type
of protection will be granted to data compilations from non-member states only if the originating
83
Directive 96/9/EC of the European Parliament and the Council of 11 March 1996 on the legal protection of
databases
84
Burk IP in e-Science supra note 3 at 5
85
Burk E-Collaborations supra note 3 at 20
27
state has similar provisions available to protect EU compilations.86 As a consequence, there is
considerable incentive for trading partners of the EU member states to enact reciprocal
legislation.87
In 1995, the European Union adopted a privacy directive with a similar reciprocity
provision, obliging member states to bring their national laws in compliance with the principles
of the Directive to in order avoid trade restrictions between EU members and other
jurisdictions88. The directive created much agitation and in response Canada enacted the
Personal Information Protection and Electronic Document Act89 (PIPEDA). The quick and
poorly drafted legislation90 was completely unresponsive to health information. The impacts on
health information were so perverse that its applicability to health information was delayed for
three years after the Act came into force in 200191. During this delay, little to nothing was done
to improve the impacts of the legislation on health information. Rather, the federal government
provided provinces and territories with an opportunity to effectively “opt-out” of PIPEDA by
enacting their own “substantially similar legislation.” Hospitals and health care providers are still
struggling to deal with the poorly drafted privacy laws.92
Whether Canada will be more cautious in complying with this directive remains to be
seen. The first attempt at reform, Bill C-60, died on the table but its successor is soon to
86
Ibid at 21
Burk IP in e-Science supra note 3 at 5
88
Gibson, Elaine. “Jewel in the Crown? The Romanow Commission Proposal to Develop a National Electronic
Health Record System” (2003), 66 Sask. L. Rev. 647.at para 23
89
S.C. 2000, c. 5 [PIPEDA]
90
PIPEDA essentially codified the Canadian Standards Association Model Code for the Protection of Personal
Information.
91
Megan Evans, Canada Personal Information Protection and Electronic Documents Act quick reference (Toronto :
Thomson Carswell, 2004)
92
Reeva Lederman. “Managing hospital databases: can large hospitals really protect patient data?” (2005), 11(3)
Health Informatics Journal 201
87
28
follow.93 The bill was controversial for a number of reasons, namely with respect to data
management rights (DMRs) and technology protection measures (TPMs) and their impacts on
the research community which are outside the scope of this paper.
Health care databases are vastly different from most databases, due largely to the
incredible complexity of the stored information and the data relationships in health care. The
complexity of clinical data is driven by the highly detailed and different data needs of diverse
care environments: inpatient, outpatient, specialist, intensive care, surgery etc.94
The challenge
will be to balance the interests of the patients, medical-scientific community and commercial
interests by, among other things, protecting the privacy of individuals, encouraging science
research, developing efficiencies and rewarding commercial effort and risk.
In a letter to the US Department of Commerce, the Presidents of the National Academy of
Sciences expressed their views about the database proposal, remarking that it would effectively
give database publishers an absolute and perpetual monopoly in their data compilations. They
refer to the effects of the proposal as long-term and deleterious on the nation’s research
capabilities and further observing that changes are broadly antiethical to the principle of full and
open exchange of scientific data. In a poignant closing, the Academy states:
What is especially disconcerting is that these radical legal changes have been
proposed by the Department of Commerce for formal discussion and negotiation
at the WIPO Diplomatic Conference this December, without any debate or
analysis of the laws potentially harmful implications for our nations scientific and
technological development. Indeed, although the unintended consequences appear
very grave to those studying these issues, very few individuals at the science
agencies or in the academic community appear even to be aware that such changes
are about to take place, nor has there been any effort made to solicit their views.95
Michael A. Einhorn “Canadian Quandary: Digital Rights Management, Access Protection, and Free Markets”
[Spring, 2004] Journal of the Copyright Society at 3
94
Alan Coltri. “Databases in Health Care” in Lehmann, Harold P. et al eds.., Aspects of Electronic Health
Record Systems (New York: Springer, 2006) 225 at 225.
95
Association of Research Libraries “National Academy of Sciences Letter with regard to The Database Proposal”
online:http://www.arl.org/arldocs/pp/ppcopyright/copyresources/dbaseleg/105congress/data.pdf
93
29
Currently, the debates surrounding database protection are discussed in isolated contexts
and without reference to EHRSs. The debates highlight the challenges of a ‘one-size fits all’
legislative framework in the diversified world of technology supported information systems.
The policies with respect to data, the set of databases where the data is stored and the associated
data relationships will establish precedents for the ownership and management policies that
govern EHRs.
CONCLUSION
While there may be a perception that IP obscures research, it is important to recognize the
reality that IP cannot be eliminated unless explicitly assigned or effectively donated to the
public.96 While this was the intended outcome of the scientific community with the Genome
Mapping Project, donating this information had little consequences because the data did not and
arguably continues to have little commercial value. The concept of open IP in other
collaborations would cripple other public-private partnerships in e-health. However, prolonging
the ownership discussion in EHRSs does little to mitigate this disruption. The results of the
IMaGE project illustrate that the default outcome of ownership interest in the collaborative
research setting can be problematic. The legislative frameworks governing these relationships
are deficient and often produce unintended results. The intellectual property polices of Infoway
and associated government bodies appear to be in a state of flux with respect to their IP policies.
The IMaGE authors proposed three distinct conceptual models of potential IP governance
of digitized medical data for secondary uses: (1) trust-centred, (2) patient-centred, and (3) a
national ownership model.
96
IP and the Integrated Health Record supra note 12 at 8
30
The trust model would be equivalent in Canada to a hospital governed model and would
maintain the status quo of hospital control and responsibility for protecting data as deemed
owner of the IP. It is recommended that standard agreements be developed for promoting open
science and research collaboration. The patient-centred model would allow patients to own the
IP in their medical record. This model could enhance the current right of access of patients
through online access without the need to request access by the physician. This would likely
involve legislative amendments and perhaps the establishment of a collecting organization to
manage patients’ new rights. The national ownership model would assign IP rights in the
medical record to a central organisation such as Infoway and would again require timely
legislative reform.
The IMaGE authors stated that the first model of hospital-centred governance seems most
feasible. Hospital centred ownership would be superior in terms of accountability and
governance and would ease the challenges of multi-jurisdiction ownership and privacy laws.
Alternatively, the Romanow report recommends individual Canadians should have
ownership over their personal health information and ready access to their personal health
records by secure on-line access.97 The report also places the burden to effectively manage the
information and technology initiative on Infoway due to its mandate and uniquely poised
position to act as a catalyst in moving forward.
Ideally, perhaps a hybrid of patient interests and hospital management will best serve the
needs of Canadians. However, one thing is clear obtaining the optimal model will require
collaboration of health care practitioners, legal experts, and government bodies.
97
Canada, Commission on the Future of Health Care in Canada, Building on Values: The Future of Health Care in
Canada - Final Report (Saskatoon: Commission on the Future of Health Care in Canada, 2002) (Chair: Roy J.
Romanow, Q.C.), online: Health Canada < http://www.hcsc.gc.ca/english/pdf/romanow/pdfs/HCC_Final_Report.pdf > at page 76,79
31
TABLE OF AUTHORITIES
Legislation:
Constitution Act, 1867
Copyright Act R.S., 1985, c. C-42
Copyright and Rights in Databases Regulations 1997, S.I. 1997 No. 3032 (UK)
Health Information Act R.S.A. 2000, c. H-5
Industrial Design Act R.S., 1985, c. I-9
Personal Health Information Protections Act, 2004, S.O. 2004, c. 3, Schedule A
Personal Information Protection and Electronic Document Act, S.C. 2000, c. 5
Public Hospitals Act, R.S.O. 1990, c. P.40
Jurisprudence:
CCH Canadian Ltd. v. Law Society of Upper Canada 2004 SCC 13
Feist Publications Inc. v. Rural Telephone Service Co., 499 U.S. 340 (1991)
McInerney v. MacDonald, [1992] 2 S.C.R. 138
Theberge v. Galerie d'Art du Petit Champlain Inc., [2002] 2 S.C.R. 336
University of London Press Ltd. v. University Tutorial Press Ltd., [1916] 2 Ch. 601
Books:
Burk, Dan L. “Intellectual Property Issues in Electronic Collaboration,” in Koslow S. and Huerta
M. eds., Electronic Collaboration in Science: Progress in Neuroinformatics, Volume 2
(Mahwah, N.J.: Lawrence Erlbaum Associates, 2000) 15.
Callens, Stefaan. E-Health & the Law (Kluwer Law International 2003)
Coltri, Alan. “Databases in Health Care” in Lehmann, Harold P. et al eds.., Aspects of Electronic
Health Record Systems (New York: Springer, 2006) 225.
Lehmann, Harold P. “Aspects of Electronic Health Record Systems” (New York: Springer,
2006)
32
Rozovsky, Lorne Elkin.,& Inions, Noela J. Canadian Health Information : A Practical Legal and
Risk Management Guide (Markham: Butterworths, 2002)
Vaver, David. Intellectual Property Law: copyright, patents, trademarks (Concord: Irwin Law,
1997)
Wieners, Walter W. et al., “The Global Perspective” in Lehmann, Harold P. et al eds.., Aspects
of Electronic Health Record Systems (New York: Springer, 2006) 176.
Articles:
Andersen, Bogi. “Icelandic Health Records” (1998) 282:5396 Science 1991, online:
http://www.sciencemag.org/cgi/content/full/282/5396/1991e
Burk, Dan L. “Intellectual Property in the context of e-Science” (2006) 12:2 Journal of
Computer-Mediated Communication.
D’Agostino, Giuseppina. et al., “On the Importance of Intellectual Property Rights for e-Science
and the Integrated Health Record” Health Informatics Journal [forthcoming in March 2008].
D’Agostino, Giuseppina. et al., “IP Rights in Medical Data in a Grid Environment (IMaGE):
Challenges to Copyright Law and Database Law” in Knowledge Rights – Legal, Societal and
Related Technological Aspects (Oesterreichische Computer Gesellschaft 2006)
D'Agostino, Giuseppina “Copyright Fight Far From Over” Masthead Jan/Feb 2007, 7
Dearne, Karen. “ Patents bid quietly laid to rest” Australian IT (23 October 2007), online:
http://www.australianit.news.com.au/story/0,24897,22630718-15319,00.html
Einhorn, Michael A.“Canadian Quandary: Digital Rights Management, Access Protection, and
Free Markets” [Spring, 2004] Journal of the Copyright Society
Epps, Tracey & Flood, Colleen M. “Have We Traded Away the Opportunity for Innovative
Health Care Reform? The Implications of the NAFTA for Medicare” (2002) 47 McGill L.J. 747
Evans, Megan. Canada Personal Information Protection and Electronic Documents Act quick
reference (Toronto : Thomson Carswell, 2004)
Frankel, Mark S. “Seizing the Moment Scientists' Authorship Rights in the Digital Age”,
Scientific Freedom, Responsibility and Law Program, American Association for the
Advancement of Science, July 2002
Gibson, Elaine. “Jewel in the Crown? The Romanow Commission Proposal to Develop a
National Electronic Health Record System” (2003), 66 Sask. L. Rev. 647.
33
Gervais, Daniel. “The Purpose of Copyright Law in Canada” (2005) 2:2 UOLTJ 315.
Geist, Michael, “Dangerous copyright proposal hit medical community hard”, (2005) 172(8)
CMAJ 989
Hlodan, Oksana, “For Sale: Iceland's Genetic History” American Institute of Biological Sciences
(June 2000), online: ActionBioscience.org:
http://www.actionbioscience.org/genomic/hlodan.html
Kleinke, J D. “ Dot-Gov: Market Failure And The Creation Of A National Health Information
Technology System” (2005) 24 (5) Health Affairs 1246.
Lederman, Reeva. “Managing hospital databases: can large hospitals really protect patient data?”
(2005), 11(3) Health Informatics Journal 201
McCaffrey, Pat. “Iceland's DeCode Genetics Struggles Toward Goal of A Nationwide Medical
Records Database” (1 April 2003) online: CIO.com
http://www.cio.com/article/31817/Iceland_s_DeCode_Genetics_Struggles_Toward_Goal_of_A_
Nationwide_Medical_Records_Database
McKie, Robin. “Icelandic DNA project hit by privacy storm” The Observer (16 May 2004)
online: http://observer.guardian.co.uk/international/story/0,6903,1217842,00.html
“Power failure for e-health” The Toronto Star (29 April 2007) A14.
Scassa, Teresa. “Interests in the Balance” in Michael Geist, ed., In the Public Interest: The
Future of Canadian Copyright Law (Toronto: Irwin Law, 2005) 41
Potter, Richard B. “Reflections through a Prism Case Comment Prism Hospital Software Inc. v.
Hospital Medical Records Institute” (1995) 18 B.L.R. (2d) 184
Trosow, Samuel E. “The Ownership and Commodification of Legal Knowledge: Using Social
Theory of the Information Age as a Tool for Policy Analysis” (2004) 30 Man. L.J. 417
von Tigerstrom, Barbara. “Protection of Health Information Privacy: The Challenges and
Possibilities of Technology” (1998) 4 Appeal 44.
Government & Policy Documents:
Association of Research Libraries “National Academy of Sciences Letter with regard to The
Database Proposal” online:
http://www.arl.org/arldocs/pp/ppcopyright/copyresources/dbaseleg/105congress/data.pdf
Black’s Law Dictionnary, 8th ed
34
Canada Health Infoway Inc. EHRS Blueprint: An interoperable EHR Framework (April 2006)
online: http://knowledge.infoway-inforoute.ca/EHRSRA/doc/EHRS-Blueprint-v2-ExecOverview.pdf
Canada Health Infoway Inc. White Paper on Information Governance of the Interoperable
Electronic Health Record (EHR) (March 2007) online:
http://www.infowayinforoute.ca/Admin/Upload/Dev/Document/Information%20Governance%20Paper%20Final_20
070328_EN.pdf
Canadian Medical Association, “Information Technology was a Top-of-Mind Issue for Delegates
Attending the CMA Annual Meeting in Edmonton Last Week” online: at
http://www.cma.ca/index.cfm/ci_id/45344/la_id/1.htm
Canadian Medical Association Health Information Privacy Code, online: Policy/Advocacy,
http://www.cma.ca/index.cfm/ci_id/3216/la_id/1.htm#prin6
Directive 96/9/EC of the European Parliament and the Council of 11 March 1996 on the legal
protection of databases
Federal Advisory Council on Health Infostructure, Canada Health Infoway: Paths to Better
Health Final Report (1999) at 3-5,online: Health Canada < http://www.hc-sc.gc.ca/hcssss/pubs/ehealth-esante/1999-paths-voies-fin/index_e.html > [ACHI, “Infoway Report”].
Health and the Information Highway
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35
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36